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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Continuation of Premarket Cohort PAS


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General
Study Status Progress Adequate
Application Number P170034 / PAS001
Study Name Continuation of Premarket Cohort PAS
General Study Protocol Parameters
Detailed Study Protocol Parameters
Study Design Description Continued follow-up PAS for the prospective, randomized, multicenter pivotal study (HORIZON Study, CP 11-001) conducted under IDE G110048 to collect additional long-term safety information. All available subjects in both the Hydrus Microstent and control groups who consented to continuation in the study will be followed 5 years postoperatively.
Sample Size Of the 556 subjects treated in this study (369 Hydrus, 187 controls), 489 subjects (334 Hydrus, 157 controls) have completed 3-year evaluations. Based on the age of the study population and other factors, it is estimated that a minimum of 70% of subjects (233 Hydrus subjects and 110 control subjects) will complete 5-year postoperative evaluations in the continuation study.

Data Collection Primary safety outcome (study eye):

Rate of occurrence of sight-threatening adverse events



Secondary safety outcomes (study eye):

Best Corrected Visual Acuity (BCVA)

Rate of occurrence of ocular adverse events

Slit lamp, gonioscopy and fundus findings

Visual field mean deviation (MD)

Central corneal thickness

Central corneal endothelial cell density (ECD)

Rate of occurrence of device malposition1

Rate of occurrence of device obstruction

Rate of occurrence of peripheral anterior synechiae (PAS)



Secondary effectiveness outcome:

Mean change in intraocular pressure (IOP)

Proportion of patients who are not using ocular hypotensive medications with a 20% or greater reduction in IOP from baseline in the HORIZON Study



1 Device malposition is considered an AE if there are associated clinical sequelae, for example: secondary surgical intervention to modify device position (i.e., repositioning or explantation), corneal endothelial touch by device, central ECL =30%, device obstruction requiring secondary surgical intervention, or chronic inflammation or irritation.

Follow-up Visits and Length of Follow-up postoperative visits at 3,4 and 5 years


Continuation of Premarket Cohort PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/08/2019 02/06/2019 On Time
one year report 08/10/2019   Overdue
18 month report 02/08/2020    
two year report 08/09/2020    
three year report 08/09/2021    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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